Recall Z-2799-2020 ยท KPS System, Tomography, Computed, Emission
Shanghai United Imaging Healthcare Co., Ltd.
uEXPLORER PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.
| Date | Aug 13, 2020 (initiated Jul 16, 2020) |
| Status | Terminated |
| Reason | 1) 1) Potential intermittent issue may cause image data problems, may lead to artifacts; 2) Potential intermittent scout scanning interruption due to angle signal drift caused by external interference; 3) Metal edge overlap of mylar strip in gantry may create sharp edge. May lead to repeat scanning and abrasions. |
| Root cause | Device Design |
| Action | Urgent Medical Device Correction Letters regarding the uEXPLORER and uMI 550 were sent to customers on July 16, 2020 via email. Customers were informed that the firm had received complaints on these products and advised customers to take the following actions if problems were observed: 1. if image artifacts occur, reboot the system and continue the reconstruction. If necessary, repeat the scan which will result in an additional dose of radiation and the possible need for additional contrast medium. 2. If scout scanning is unexpectedly interrupted, try repeating the scout. This will result |
| Quantity | 1 unit distributed to Texas |
| Distribution | US Nationwide distribution including in the state of Texas. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K182938 | Emission Computed Tomography System Shanghai United Imaging Healthcare Co., Ltd., Dec 18, 2018 |